Bioequivalence and Bioavailability Forum • Lin/log trapezoidal

Lin/log trapezoidal [Design Issues]

posted by Helmut – Vienna, Austria, 2013-11-17 15:55 (4603 d 18:31 ago) – Posting: # 11902
Views: 9,979

Hi Ohlbe & Nathan,

❝ No guideline says that the linear trapezoidal rule should be used for BE. The method should be stated in the protocol and in the report, that's all.

Exactly. The WHO stated in 2006:

The method of calculating AUC-values should be speciﬁed. In general AUC should be calculated using the linear/log trapezoidal integration method.

(my emphasis)

❝ Sponsors and CROs are just keeping that habit for whatever reason.

Why the wacky linear trapezoidal rule is still of such widespread use is a complete mystery to me. Its bad performance was shown decades ago. I’m happy that in bear the lin-up/log-down is the default since v2.5.6 (June 27, 2013) and Pharsight will follow in the next release of Phoenix/WinNonlin (expected in Q I / 2014).

—
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Helmut Schütz

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Complete thread:

Using sampling “windows” for PK blood samples mittyri 2013-10-23 09:53
- Using sampling “windows” for PK blood samples jag009 2013-10-23 16:50
  - Using sampling “windows” for PK blood samples mittyri 2013-10-24 15:35
    - Using sampling “windows” for PK blood samples jag009 2013-10-25 05:12
      - Disagree with Nathan Helmut 2013-10-28 15:48
        
        Disagree with Nathan jag009 2013-10-28 20:36
      - Using sampling “windows” for PK blood samples teuscher 2013-11-15 03:55
        
        Using sampling “windows” for PK blood samples Ohlbe 2013-11-15 10:32
        
        Using sampling “windows” for PK blood samples teuscher 2013-11-15 15:16
        
        Using sampling “windows” for PK blood samples Ohlbe 2013-11-15 15:55
        
        Lin/log trapezoidalHelmut 2013-11-17 14:55